F2025L00414Therapeutic Goods Legislation Checker

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Free scope and date check

Answer the role, the device class and the certificate questions. The check returns the general start day, the 30th day for the database entry, the direct marking date where it applies, and the adverse event stage for a facility.

Free scope and date check

Three minutes, no account

The check reads the dates in the record. Nothing you type leaves this page.

Your role
Choose the class on the ARTG. An in-house IVD is outside the UDI medical device definition.
Is the device implantable?

This matters for a Class III device intended for reprocessing: an implantable device is outside the direct marking duty. If you are unsure, check the intended use; do not assume no.

Directive certificate at the class cut-off

Cut-offs: 30 June 2028 for Class I sterile, Class 3 IVD; 30 June 2027 for Class IIa; 30 June 2026 for Class IIb and III; 30 June 2029 for Class 1 and Class 2 IVD. Class 4 IVD has no certificate branch. An MDR 2017/745 certificate does not meet the defined term, so answer no if that is all you hold.

Stock condition, Class IIb and III only

The cut-off is 1 January 2028 for Class III and implantable Class IIb with an EU certificate, 1 January 2029 for non-implantable Class IIb with a certificate, and 1 July 2026 without a certificate.

Direct marking
Leave blank if it has not happened. The 30-day clock starts on this date, not on the ARTG inclusion date.
Authorised representative information

Not legal advice; does not certify. The check does not decide whether a device is a UDI medical device or whether an event is reportable.

Start with your role.

The result appears here with the dates, the privacy step and the evidence list. Nothing is sent anywhere; the check runs in this page.

How the dates are read

The general start day comes from the dictionary in Schedule 1 item 7. It uses the class, the EU certificate in force on the named cut-off, and the stock condition for Class IIb and III. The database window is 30 days beginning on the first supply day on or after that start day. The direct marking start day is a separate class table.

The check does not decide whether a device is a UDI medical device. That is the class list in the dictionary, read against the ARTG entry. It does not decide whether an event is reportable. That is the Act and regulation 8AA.3.

Not legal advice; does not certify. How the record is built.

What the result means

Start day

The date the duties attach

The UDI supply, import and export rules apply from the device general start day. A past date means the rules have already started. A future date is the planning date for the label, the database entry and the evidence.

30th day

The database window

The period begins on the first supply day on or after the general start day. Counting that day as day 1, the last day is the 30th day. The ARTG inclusion date is not the trigger.

Privacy

Consent before entry

Representative information needs written consent before it enters the database. It must not be published and must be removed on a written request. The result names the clause and the evidence to keep.